mk-8510 monotherapy for the treatment of anti-retroviral naïve human immunodeficiency virus type 1 (hiv-1) infected participants (mk-8510-002)

Conditions: HIV-1; Human Immunodeficiency Virus 1; Immunodeficiency Virus Type 1, Human; Human Immunodeficiency Virus Type 1

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and anti-retroviral activity of mk-8510 monotherapy in anti-retroviral-naïve hiv-1 infected participants.


Eligibility criteria:
inclusion criteria: * has hiv-1 infection, and is in good health based on medical history, physical examination, vital signs (vs) measurements, and laboratory safety tests. * has documented hiv-1 positive, as determined by a positive enzyme-linked immunosorbent assay (elisa) or real-time quantitative polymerase chain reaction (qt-pcr) with confirmation (eg, western blot). * is anti-retroviral therapy (art)-naïve, which is defined as: 1. having never received any anti-retroviral agent; or 2. art-experienced but has not received any art for hiv-1 infection within 60 days; or 3. has received pre-exposure prophylaxis (prep) treatment prior to diagnosis of hiv-infection but has not received any prep within 30 days. * is willing to receive no other art prior to day 11 post-dose of the study. * has a body mass index (bmi) ≤35 kg/m2. exclusion criteria: * has acute (primary) hiv-1 infection. * has a history of clinically significant endocrine, gastrointestinal (gi), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases. * has remote history of uncomplicated medical events (eg, uncomplicated kidney stones, as defined as spontaneous passage and no recurrence in the last 5 years, or childhood asthma). * is mentally or legally incapacitated or has significant emotional problems. * has history of cancer (malignancy). * has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy), or has had an anaphylactic reaction or significant intolerability (i.e, systemic allergic reaction) to prescription or nonprescription drugs or food. * has positive hepatitis b surface antigen (hbsag). * has a history of chronic hepatitis c unless there has been documented cure and/or participant with a positive serologic test for hepatitis c virus (hcv) has a negative hcv viral load (vl). * had a major surgery and/or donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit. * has participated in another investigational study within 4 weeks. * has a clinically significant abnormality on the electrocardiogram (ecg) performed at the pre-study visit. * has been committed to an institution by way of official or judicial order. * is under the age of legal consent or not capable of giving consent. * does not agree to follow the smoking restrictions as defined by the clinical research unit (cru). * consumes greater than 3 servings of alcoholic beverages (1 serving is approximately equivalent to: beer \[354 ml/12 ounces\], wine \[118 ml/4 ounces\], or distilled spirits \[29.5 ml/1 ounce\]) per day. * consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day. * is a regular user of any illicit drugs (not including cannabis) or has an history of drug (including alcohol) abuse within approximately 12 months.